Pentazocine and naloxone

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Overview

What is Pentazocine and naloxone?

Pentazocine and naloxone hydrochlorides tablets USP contain pentazocine hydrochloride USP, equivalent to 50 mg base, a member of the benzazocine series (also known as the benzomorphan series), and naloxone hydrochloride USP, equivalent to 0.5 mg base.

Pentazocine and naloxone hydrochlorides tablets are an analgesic for oral administration.

Chemically, pentazocine hydrochloride is (2*, 6*, 11*)-1,2,3,4,5,6-Hexahydro-6,11-dimethyl-3-(3-methyl-2-butenyl)-2,6-methano-3-benzazocin-8-ol hydrochloride, a white, crystalline substance soluble in acidic aqueous solutions. It has the following structural formula:

Chemically, naloxone hydrochloride is 17-AIlyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride. It is a slightly off-white powder, and is soluble in water and dilute acids. It has the following structural formula:

Each tablet, for oral administration, contains pentazocine hydrochloride USP, equivalent to 50 mg of pentazocine, and naloxone hydrochloride USP, equivalent to 0.5 mg of naloxone. In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate, D&C Yellow No. 10 Al-lake, FD&C Blue No. 1 Al-lake, FD&C Yellow No. 6 Al-lake, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium lauryl sulfate.

What does Pentazocine and naloxone look like?

What are the available doses of Pentazocine and naloxone?

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What should I talk to my health care provider before I take Pentazocine and naloxone?

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How should I use Pentazocine and naloxone?

Pentazocine and naloxone hydrochlorides tablets are indicated for the relief of moderate to severe pain.

Pentazocine and naloxone hydrochlorides tablets are indicated for oral use only.

Adults.

When anti-inflammatory or antipyretic effects are desired in addition to analgesia, aspirin can be administered concomitantly with this product.

Pediatric Patients.

Duration of Therapy.

What interacts with Pentazocine and naloxone?

Pentazocine and naloxone hydrochlorides tablets should not be administered to patients who are hypersensitive to either pentazocine or naloxone.

What are the warnings of Pentazocine and naloxone?

Array

Drug Dependence.

Head Injury and Increased Intracranial Pressure.

Usage with Alcohol.

Patients Receiving Narcotics.

Certain Respiratory Conditions.

Acute CNS Manifestations.

What are the precautions of Pentazocine and naloxone?

CNS Effect

Caution should be used when pentazocine is administered to patients prone to seizures; seizures have occurred in a few such patients in association with the use of pentazocine though no cause and effect relationship has been established.

Impaired Renal or Hepatic Function

Decreased metabolism of pentazocine by the liver in extensive liver disease may predispose to accentuation of side effects. Although laboratory tests have not indicated that pentazocine causes or increases renal or hepatic impairment, the drug should be administered with caution to patients with such impairment.

In prescribing pentazocine for long-term use, the physician should take precautions to avoid increases in doses by the patient.

Biliary Surgery

Narcotic drug products are generally considered to elevate biliary tract pressure for varying periods following their administration. Some evidence suggests that pentazocine may differ from other marketed narcotics in this respect (i.e., it causes little or no elevation in biliary tract pressures). The clinical significance of these findings, however, is not yet known.

Information for Patients

Since sedation, dizziness, and occasional euphoria have been noted, ambulatory patients should be warned not to operate machinery, drive cars, or unnecessarily expose themselves to hazards. Pentazocine may cause physical and psychological dependence when taken alone and may have additive CNS depressant properties when taken in combination with alcohol or other CNS depressants.

Myocardial Infarction

As with all drugs, pentazocine should be used with caution in patients with myocardial infarction who have nausea or vomiting.

Drug Interactions

Usage with Alcohol:

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term studies in animals to test for carcinogenesis have been performed with the components of pentazocine and naloxone hydrochlorides tablets.

Pregnancy Category C

Animal reproduction studies have not been conducted with pentazocine and naloxone hydrochlorides. It is also not known whether pentazocine and naloxone hydrochlorides tablets can cause fetal harm when administered to pregnant women or can affect reproduction capacity. Pentazocine and naloxone hydrochlorides tablets should be given to pregnant women only if clearly needed. However, animal reproduction studies with pentazocine have not demonstrated teratogenic or embryotoxic effects.

Labor and Delivery

Patients receiving pentazocine during labor have experienced no adverse effects other than those that occur with commonly used analgesics. Pentazocine and naloxone hydrochlorides tablets should be used with caution in women delivering premature infants. The effect of pentazocine and naloxone hydrochlorides tablets on the mother and fetus, the duration of labor and delivery, the possibility that forceps delivery or other intervention or resuscitation of the newborn may be necessary, or the effect of pentazocine and naloxone hydrochlorides tablets on the later growth, development, and functional maturation of the child are unknown at the present time.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when pentazocine and naloxone hydrochlorides tablets are administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 12 years have not been established.

Geriatric Use

Controlled clinical studies of pentazocine and naloxone hydrochlorides tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses or effectiveness in analgesic activity between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

What are the side effects of Pentazocine and naloxone?

Cardiovascular:

Respiratory:

Acute CNS Manifestations:

Other CNS Effects:

Autonomic:

Gastrointestinal:

Allergic:

Ophthalmic:

Hematologic:

Other:

What should I look out for while using Pentazocine and naloxone?

Pentazocine and naloxone hydrochlorides tablets should not be administered to patients who are hypersensitive to either pentazocine or naloxone.

Drug Dependence.

Head Injury and Increased Intracranial Pressure.

Usage with Alcohol.

Patients Receiving Narcotics.

Certain Respiratory Conditions.

Acute CNS Manifestations.

What might happen if I take too much Pentazocine and naloxone?

Manifestations.

Treatment.

How should I store and handle Pentazocine and naloxone?

Procedures for proper handling and disposal should be considered. Consideration should be given to handling and disposal according to guidelines issued for cytotoxic drugs. Several guidelines on this subject have been published. Caution should be exercised in the handling and preparation of Fludarabine Phosphate Injection solution. The use of latex gloves and safety glasses is recommended to avoid exposure in case of breakage of the vial or other accidental spillage. If the solution contacts the skin or mucous membranes, wash thoroughly with soap and water; rinse eyes thoroughly with plain water. Avoid exposure by inhalation or by direct contact of the skin or mucous membranes.Pentazocine and Naloxone Hydrochlorides Tablets USP are light green, scored, capsule shaped tablets debossed to the left of the score, over to the right of the score and on the reverse side.They are supplied by as follows:Store at controlled room temperature 15°-30°C (59°-86°F). [See USP.]Dispense in a tight, light-resistant container as defined in the USP.Watson Laboratories, Inc.This Product was Repackaged By Sandhills Packaging For:Keltman Pharmaceuticals Inc.Pentazocine and Naloxone Hydrochlorides Tablets USP are light green, scored, capsule shaped tablets debossed to the left of the score, over to the right of the score and on the reverse side.They are supplied by as follows:Store at controlled room temperature 15°-30°C (59°-86°F). [See USP.]Dispense in a tight, light-resistant container as defined in the USP.Watson Laboratories, Inc.This Product was Repackaged By Sandhills Packaging For:Keltman Pharmaceuticals Inc.Pentazocine and Naloxone Hydrochlorides Tablets USP are light green, scored, capsule shaped tablets debossed to the left of the score, over to the right of the score and on the reverse side.They are supplied by as follows:Store at controlled room temperature 15°-30°C (59°-86°F). [See USP.]Dispense in a tight, light-resistant container as defined in the USP.Watson Laboratories, Inc.This Product was Repackaged By Sandhills Packaging For:Keltman Pharmaceuticals Inc.Pentazocine and Naloxone Hydrochlorides Tablets USP are light green, scored, capsule shaped tablets debossed to the left of the score, over to the right of the score and on the reverse side.They are supplied by as follows:Store at controlled room temperature 15°-30°C (59°-86°F). [See USP.]Dispense in a tight, light-resistant container as defined in the USP.Watson Laboratories, Inc.This Product was Repackaged By Sandhills Packaging For:Keltman Pharmaceuticals Inc.Pentazocine and Naloxone Hydrochlorides Tablets USP are light green, scored, capsule shaped tablets debossed to the left of the score, over to the right of the score and on the reverse side.They are supplied by as follows:Store at controlled room temperature 15°-30°C (59°-86°F). [See USP.]Dispense in a tight, light-resistant container as defined in the USP.Watson Laboratories, Inc.This Product was Repackaged By Sandhills Packaging For:Keltman Pharmaceuticals Inc.Pentazocine and Naloxone Hydrochlorides Tablets USP are light green, scored, capsule shaped tablets debossed to the left of the score, over to the right of the score and on the reverse side.They are supplied by as follows:Store at controlled room temperature 15°-30°C (59°-86°F). [See USP.]Dispense in a tight, light-resistant container as defined in the USP.Watson Laboratories, Inc.This Product was Repackaged By Sandhills Packaging For:Keltman Pharmaceuticals Inc.Pentazocine and Naloxone Hydrochlorides Tablets USP are light green, scored, capsule shaped tablets debossed to the left of the score, over to the right of the score and on the reverse side.They are supplied by as follows:Store at controlled room temperature 15°-30°C (59°-86°F). [See USP.]Dispense in a tight, light-resistant container as defined in the USP.Watson Laboratories, Inc.This Product was Repackaged By Sandhills Packaging For:Keltman Pharmaceuticals Inc.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Pentazocine is a potent analgesic which when administered orally in a 50 mg dose appears equivalent in analgesic effect to 60 mg (1 grain) of codeine. Onset of significant analgesia usually occurs between 15 and 30 minutes after oral administration, and duration of action is usually three hours or longer. Onset and duration of action and the degree of pain relief are related both to dose and the severity of pretreatment pain. Pentazocine weakly antagonizes the analgesic effects of morphine and meperidine; in addition, it produces incomplete reversal of cardiovascular, respiratory, and behavioral depression induced by morphine and meperidine. Pentazocine has about 1/50 the antagonistic activity of nalorphine. It also has sedative activity.

Pentazocine is well absorbed from the gastrointestinal tract. Concentrations in plasma coincide closely with the onset, duration, and intensity of analgesia; peak values occur 1 to 3 hours after oral administration. The half-life in plasma is 2 to 3 hours.

Pentazocine is metabolized in the liver and excreted primarily in the urine. Pentazocine passes into the fetal circulation.

Naloxone when administered orally at 0.5 mg has no pharmacologic activity. Naloxone hydrochloride administered parenterally at the same dose is an effective antagonist to pentazocine and a pure antagonist to narcotic analgesics.

Pentazocine and naloxone hydrochlorides tablets are a potent analgesic when administered orally. However the presence of naloxone in pentazocine and naloxone naloxone hydrochlorides tablets will prevent the effect of pentazocine if the product is misused by injection.

Studies in animals indicate that the presence of naloxone does not affect pentazocine analgesia when the combination is given orally. If the combination is given by injection the action of pentazocine is neutralized.

Non-Clinical Toxicology

Pentazocine and naloxone hydrochlorides tablets should not be administered to patients who are hypersensitive to either pentazocine or naloxone.

Drug Dependence.

Head Injury and Increased Intracranial Pressure.

Usage with Alcohol.

Patients Receiving Narcotics.

Certain Respiratory Conditions.

Acute CNS Manifestations.

Usage with Alcohol:

Caution should be used when pentazocine is administered to patients prone to seizures; seizures have occurred in a few such patients in association with the use of pentazocine though no cause and effect relationship has been established.

Cardiovascular:

Respiratory:

Acute CNS Manifestations:

Other CNS Effects:

Autonomic:

Gastrointestinal:

Allergic:

Ophthalmic:

Hematologic:

Other:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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